Status:
UNKNOWN
Study of Surgical Mesh for Inguinal Hernia Repair
Lead Sponsor:
Biomerix
Conditions:
Hernia, Inguinal
Eligibility:
MALE
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, ope...
Eligibility Criteria
Inclusion
- male ≥19 years old
- symptomatic and palpable inguinal hernia
- candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
- will comply with required follow-up study visits
- willing and able to provide written informed consent
Exclusion
- BMI ≥35
- life expectancy of \<3 years
- strangulated hernia
- urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
- active abdominal surgical condition such as bowel obstruction or perforation
- local or systemic infection or peritonitis
- known disease that impairs wound healing
- anti-platelet therapy (other than aspirin) for \>7 days preceding the surgical procedure
- previous ipsilateral groin incision
- receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
- uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
- advanced cirrhosis with Child-Turcott Class of C or higher
- severe COPD requiring home oxygen
- diagnosed with chronic pain syndrome or is undergoing treatment for pain management
- candidate for another major surgical procedure with the inguinal hernia repair
- enrolled in another investigational study that may confound the results of this study
- known drug abuser
- on anti-psychotic medications
- Worker's Compensation case
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00924755
Start Date
June 1 2009
End Date
November 1 2010
Last Update
October 4 2010
Active Locations (2)
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1
Creighton University
Omaha, Nebraska, United States, 68178
2
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030